fda_recall · device_recall · critical
Datex-Ohmeda Inc — Class I recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (r…
- Event date
- 2026-06-24 00:00:00Z
- Observed
- 2026-07-09 22:52:02Z
- Source ID
- Z-2357-2026
- Payload hash
- c3a190121381e57f871db1eb…
Summary
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.